PI-330303-AE ZelanteDVT In-Service Updated EIP FINAL

In-Service
1 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. PI-xxxxxx-AA AUG2015
IMPORTANT INFORMATION
These materials are intended to describe common clinical considerations and

procedural steps for the on-label use of referenced technologies as well as
current standards of care for certain conditions.
Of course, patients and their medical circumstances vary, so the clinical
considerations and procedural steps described may not be appropriate for
every patient or case.
As always, decisions surrounding patient care depend on the physician’s
professional judgment in light of all available information for the case at hand.
BSC does not promote or encourage the use of its devices outside their
approved labeling.
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
Information for the use only in countries with applicable health authority product registrations.
This material is not intended for use or distribution in France.
2 ©©2015
2015Boston Scientific
Boston Corporation
Scientific or its affiliates.
Corporation All rightsAll
or its affiliates. reserved. PI-xxxxxx-AA
rights reserved. PI-330303-AE
AUG2015 DECEMBER 2015
The AngioJet™ System Overview
The AngioJet Thrombectomy System is designed to remove thrombus, providing

options for improved patient outcomes and decreased complications.
Potential benefits with thrombus removal1:

• Quick restoration of flow
• Improved vessel and target lesion visualization
• Decreased risk of distal embolization and resulting complications
• The option of pharmacomechanical combination therapy and the ability to
treat thrombus of various age
1. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL
(Peripheral Use Of Angiojet Rheolytic Thrombectomy with a Variety Of Catheter Lenghts) Registry. Mark J. Garcia, MD, RVT, et al. JVIR Vol. 26, Issue
6, June 2015, Page 777-785.
3 ©©2015
Boston Corporation
ZelanteDVT catheter
Specifications ZelanteDVT
INDICATIONS AND USAGE
The ZelanteDVT Thrombectomy Set is intended for Vessel Diameter > 6mm
use with the AngioJet Ultra Console to break apart
Working Length 105cm
and remove thrombus, including deep vein
thrombus (DVT), from: Shaft Diameter 8F *
Iliofemoral and lower extremity veins ≥ 6.0 mm in
diameter and Upper extremity peripheral veins ≥ OTW 0.035”
6.0 mm in diameter.
Double Marker Band 15 mm
The ZelanteDVT Thrombectomy Set is also
intended for use with the AngioJet Ultra Power Maximum run time 8 min
Pulse® technique for the controlled and selective
infusion of physician specified fluids, including Max run time with blood flow: 4 min
thrombolytic agents, into the peripheral vascular
system. Flow Rate 60 ml/min
Power Pulse delivery 0.6ml per stroke
CONTRAINDICATIONS
Do not use the catheter in patients: Introducer Sheath 8F*
• Who are contraindicated for endovascular
procedures Number of Main Jets 5
• Who cannot tolerate contrast media Catalogue Number 114610
• In whom the lesion cannot be accessed with GTIN: 08714729904731
the guidewire
Shelf Life 2 Years
4 ©©2015
Boston Corporation
AUG2015 DECEMBER * 3F=1,00mm 4F:1,33mm/ 6F=2,0mm 8F=2,7mm
0,014’’=0,356mm/0,035’’= 0,889mm
AngioJet™ VENOUS Catheter
ZelanteDVT™
• ~4x thrombus removal power vs. Solent™ Omni and Proxi
• 8 F, 105 cm length, 0.035”* guidewire
• Power Pulse™ enabled
• 6 mm minimum venous diameter
* 8F=2,7mm, 0,035’’= 0,889mm

5 ©©2015
Boston Corporation
ZelanteDVT™ Catheter Overview
• Directional Thrombectomy
• Single (larger) inflow window
o Surface area similar to Omni and Proxi windows
• Similar hemolysis profile to Solent™ Omni
One inflow window One outflow window
6 ©©2015
Boston Corporation
Catheter direction / rotation knob
Dedicated guidewire
lumen
Contrast injection port
7 ©©2015
Boston Corporation
Catheter direction / rotation knob
• Rotator has a built in stop allowing ~320

degree rotation
DO NOT rotate the knob beyond the built

in stop. Over torqueing may result in
catheter damage
• When reaching rotator stop, turn rotator in

counter direction away from stop point
8 ©©2015
Boston Corporation
ZelanteDVT™ rotation technique video
9 ©©2015
Boston Corporation
AngioJet Catheter Comparison
Product Feature(s) Solent™ Omni / Proxi ZelanteDVT™

Indication Arterial and Venous Venous Only
Minimum Vessel Diameter 3 mm 6 mm
Sheath Compatibility 6F* 8F*
Working Length 120 cm / 90 cm 105 cm
~4x thrombus removal
Thrombectomy Power
power than Omni & Proxi1
Power Pulse™ enabled Yes
Contrast Injection Port Yes
Wire Compatibility 0.035“ *
Guide Wire Swappable Yes
Run Times (No Flow / Flow) 8 minutes / 4 minutes 8 minutes / 4 minutes
Power Pulse™ Delivery 0.6 mL / pump stroke 0.6 mL / pump stroke
1Bench data on file * 3F=1,00mm 4F:1,33mm/ 6F=2,0mm 8F=2,7mm
10 ©©2015
Boston Corporation
rights reserved. PI-330303-AE 0,014’’=0,356mm/0,035’’=
AUG2015 DECEMBER 2015 0,889mm
Bench Simulation Thrombectomy Power
ZelanteDVT™ offers ~4x the thrombus removal power than

Solent™ Omni and Proxi1 catheters
Proxi - Omni ZelanteDVT
Similar run times (3 passes), in 22 mm diameter

clot tubes, with the catheter positioned in the
middle of the tube (not rotated)
1Bench test data on file
11 ©©2015
Boston Corporation
Bench Simulation1 Power Pulse™ Delivery
Solent Omni ZelanteDVT
1Bench test data on file
12 ©©2015
Boston Corporation
ZelanteDVT™ Window Indicator Band
15 mm
Indicator band
opposite
Inflow & Outflow
windows
13 ©©2015
Boston Corporation
Contrast Injection with AngioJet™ Catheter*
• DO NOT inject fluids through the stopcock unless

the catheter has operated in blood for at least 30
seconds prior to injection
• DO NOT use negative pressure from a syringe to

try to purge the catheter
• The manifold must be purged using blood return

at systemic pressure through the stopcock.
• Rotate the manifold until the stopcock is oriented

toward the ceiling and open until 3cc of blood has
escaped through the stopcock.
• Make a fluid to fluid connection between the

injecting syringe and stopcock leg prior to
delivery of contrast.
• Open the stopcock and inject the physician

specified fluid.
* Refer to the Technical Bulletin on contrast injection and AngioJet catheter Information for Use
14 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. PI-xxxxxx-AA AUG2015 PI-330303-AE DECEMBER 2015
Notes on technique
• Contrary to all other AngioJet catheters, Zelante is directional, so it is much more effective in
removing thrombus on the side where the windows are located.
• Advance or retract the catheter at a speed of approximately 1-3 mm/sec. During
thrombectomy, there are two possible advancing techniques:
– Activate, then rotate 180, then activate: Perform one proximal to distal pass without rotating the
catheter, followed by a 180 degree rotation and a second proximal to distal pass
– Activate while rotating: Perform a proximal to distal pass while slowly rotating the knob clockwise to
the stop, then counterclockwise to the stop, to ensure that the windows can remove all the thrombus
circumferentially.
• Actual technique is up to the user, although the “activate while rotating” technique has shown
slightly better results during LME cases.
• Any rotation of the knob should result in an approximately equal rotation of the catheter tip, as
seen by the indicator band and the marker bands.
• Keep in mind that the catheter cannot be used in vessels smaller than 6mm. Therefore, the
catheter should not be activated while crossing stenoses that are tighter than 6mm, even if the
local reference (healthy) vessel diameter is larger than 6mm.
• If possible, utilize the position of the indicator band to ensure that the windows are not forced
into continuous direct contact with the vessel wall.
• The indicator band is located opposite to the 2 windows. When the indicator seems to be in
the middle of the catheter shaft, the windows could be facing up or down.
PI-330303-AE DECEMBER 2015
15 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. PI-xxxxxx-AA AUG2015
ZelanteDVT™ case report
Pharmacomechanical treatment of subacute Iliofemoral DVT
Baseline Distal Baseline Proximal AngioJet™ Thrombectomy Post AngioJet™ Thrombectomy
Complete occlusion of Superficial Complete occlusion of Common ZelanteDVT catheter activated for Complete thrombus removal
Femoral vein. Iliac and Common Femoral vein, 20 sec in Power Pulse mode following thrombectomy with the
Subacute thrombus (14-30 days due to severe stenosis of Common utilizing tPA, followed by 20 minutes ZelanteDVT catheter, indicating the
old) Iliac Vein. wait time and AngioJet severe proximal stenosis of the
thrombectomy (2 passes proximal to common iliac vein. The stenosis
distal in thrombectomy mode while was successfully treated with PTA.
Dr Said Habib, Queens Medical Centre, Nottingham, UK continuously spiraling the tip of the
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
catheter)
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with
each device. Information for the use only in countries with applicable health authority product registrations. AngioJet, Solent and Power Pulse may be registered trademarks of Bayer in the US and other countries; AngioJet Thrombectomy products are distributed by
Boston Scientific Corporation in some countries. All other trademarks are property of their respective owners. This material is not intended for use or distribution in France. © 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
PI-…..-AA
16 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. PI-xxxxxx-AA AUG2015 PI-330303-AE DECEMBER 2015
Catheter Reference & Ordering Information
Maximum Run
times
Minimum Catheter Total Run time
Order Power Pulse™ Delivery Guide Catheter Introducer
Model Indication Vessel Diameter Run with Blood
Information Enabled Platform Wire Length Sheath
Diameter (F*) Time Flow
ZelanteDVT™ 114610 Peripheral Venous YES OTW 0.035" 6 mm 105cm 8F 8F 480 sec 240 sec
Peripheral Arterial
Solent™
109681 and Venous, AV YES OTW 0.035" 3 mm 120 cm 6F 6F 480 sec 240 sec
Omni
Access
Peripheral Arterial
Solent™
109676 and Venous, AV YES OTW 0.035" 3 mm 90 cm 6F 6F 480 sec 240 sec
Proxi
Access
Solent™ 4F/3F
111303 Peripheral Arterial YES OTW 0.014" 1.5 mm 145 cm 4F 600 sec 300 sec
Dista distal
Main Pulmonary and
PE 107171 YES OTW 0.035" 6 mm 120 cm 6F 6F 600 sec 300 sec
Lobar Arteries
AVX™ 105039 AV Access NO OTW 0.035" 3 mm 50 cm 6F 6F 600 sec 300 sec
* 3F=1,00mm 4F:1,33mm/ 6F=2,0mm 8F=2,7mm
0,014’’=0,356mm/0,035’’= 0,889mm
17 ©©2015
Boston Corporation
Disease State Treatments & Peripheral Offerings
DVT, PAD, PE, & AV Access Declot
ARTERIAL VENOUS
Upper Extremity Pulmonary Upper Extremity

SOLENT™ Embolism SOLENT
Omni / Proxi Omni / Proxi
PE Catheter
ZELANTEDVT™
AV Access
Lower Extremity ATK
AVX™-CI
SOLENT
Catheter Lower Extremity
Omni / Proxi
ATK
ZELANTEDVT
Below Extremity BTK SOLENT
SOLENT Dista Omni / Proxi
DVT-Deep Vein Thrombosis; PAD-Peripheral Arterial Disease; PE-Pulmonary Embolism; AV-Arterial Venous
PE catheter approved
18 ©©2015
Boston Corporation
Abbreviated Statement
Angiojet, AVX, Power Pulse, and Solent are registered or unregistered trademarks of Boston Scientific
Corporation or its affiliates. All other trademarks are property of their respective owners.
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to
sale by or on the order of a physician .
Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied
with each device. Information for the use only in countries with applicable health authority product registrations.
Indications, operating specifications and availability may vary by country. Check with local product representation
and country-specific Information For Use for your country. This Material is not approved for use or distribution in
France.
19 ©©2015
Boston Corporation

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In-Service

These materials are intended to describe common clinical considerations and

The AngioJet Thrombectomy System is designed to remove thrombus, providing

Potential benefits with thrombus removal1:

• 8 F, 105 cm length, 0.035”* guidewire

• Power Pulse™ enabled

• 6 mm minimum venous diameter

* 8F=2,7mm, 0,035’’= 0,889mm

o Surface area similar to Omni and Proxi windows

• Similar hemolysis profile to Solent™ Omni

One inflow window One outflow window

Catheter direction / rotation knob

Contrast injection port

Catheter direction / rotation knob

• Rotator has a built in stop allowing ~320

DO NOT rotate the knob beyond the built

• When reaching rotator stop, turn rotator in

Product Feature(s) Solent™ Omni / Proxi ZelanteDVT™

ZelanteDVT™ offers ~4x the thrombus removal power than

Proxi - Omni ZelanteDVT

Similar run times (3 passes), in 22 mm diameter

Solent Omni ZelanteDVT

1Bench test data on file

• DO NOT inject fluids through the stopcock unless

• DO NOT use negative pressure from a syringe to

• The manifold must be purged using blood return

• Rotate the manifold until the stopcock is oriented

• Make a fluid to fluid connection between the

• Open the stopcock and inject the physician

Pharmacomechanical treatment of subacute Iliofemoral DVT

Baseline Distal Baseline Proximal AngioJet™ Thrombectomy Post AngioJet™ Thrombectomy

Upper Extremity Pulmonary Upper Extremity

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